đź“‹ FDA Reference
tubing conmnectors and accessories wit balance biosurface
Medtronic
Summary: The tubing connectors and accessories with balance biosurface by Medtronic are used in ablation procedures for tumors. They are typically utilized by interventional radiologists and oncologists in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K113845 ↗
Decision Date
January 25, 2012
Product Code
DTL
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on January 25, 2012. It is manufactured by Medtronic and classified as a Class 2 medical device under product code DTL.
What It Is
This device comprises tubing connectors and accessories designed with a balance biosurface to facilitate ablation procedures. Ablation is a minimally invasive treatment that uses heat or cold to destroy cancer cells. The balance biosurface is engineered to optimize fluid dynamics and reduce clot formation, enhancing procedural safety and efficacy.
Clinical Applications
These tubing connectors are commonly used in tumor ablation procedures, particularly in interventional radiology and oncology settings. They are essential in procedures such as radiofrequency ablation, microwave ablation, and cryoablation, where precise fluid management is critical. The device is suitable for adult patients undergoing minimally invasive tumor treatments.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures that require precise fluid management during tumor ablation. It is particularly useful for patients with tumors that are accessible via minimally invasive techniques.
Practical Considerations
The device is compatible with standard ablation systems and is available in various sizes to accommodate different procedural needs. Clinicians should ensure compatibility with existing equipment and be familiar with the specific technique requirements for optimal use.
Related Literature
The linked study explored the generation of veiled accessory cells from monocytes, comparing them to dendritic cells. Key findings indicated that these cells, when cultured under specific conditions, exhibited movement patterns similar to lymph-borne cells. While the study provides insights into cellular behavior, its direct relevance to the tubing connectors is limited.
Frequently Asked Questions
What is tubing connectors and accessories with balance biosurface used for?
They are used in tumor ablation procedures to manage fluid dynamics and reduce clot formation.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures requiring precise fluid management.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.